Pre-clinical evaluation of titanium nitride coated titanium material

Abstract

The titanium nitride coated titanium is a material intended for the fabrication of left ventricular assist device. As per International standards, a material is subjected to pre-clinical evaluation before fabrication of a device. Toxicity/biocompatibility studies such as acute systemic toxicity, intracutaneous irritation, in vitro haemolysis and implantation in muscle were studied as per international standards for the titanium nitride coated titanium. Acute systemic toxicity was studied in mice using physiological saline and cotton seed oil extracts of the material. Intracutaneous irritation was done by injecting the extracts of the test material and control intradermally into rabbits. Grading of erythema and oedema of test and control animals were recorded at 24, 48 and 72 h. In vitro haemolysis was carried out with material and extract of the material with rabbit blood. The muscle implantation was carried out in nine anesthetized rabbits. The implanted animals were sacrificed at the end of 1, 4 and 12 weeks, the tissue with the implanted materials were collected and subjected to histopathological analysis. The results of the study did not show any significant irritation or systemic toxicity with physiological saline and cotton seed oil extracts of the material. The percentage of hemolysis induced by the material and extract was under acceptable range. Results of the histopathological evaluation suggest that the test material did not produce any cellular changes. Hence the present study concluded that the test material is non-toxic, non-irritant, non-haemolytic and biocompatible.